Intramedullary Fixation Scaffold (IFS)

FDA UDI

Class II (US FDA UDI)

by Metric Medical Devices, Inc.

Identity

Trade Name: Intramedullary Fixation Scaffold (IFS) FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 3ea K-wires with sharps protection, and 1ea Drill Bit with integral handle for manual use. FDA UDI
Model / Reference: IFS2.5 FDA UDI
Description: Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 3ea K-wires with sharps protection, and 1ea Drill Bit with integral handle for manual use. FDA UDI

Identifiers

Catalog Number: IFS2.5 FDA UDI
Primary DI / UDI-DI: M963IFS250 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.5 Millimeter FDA UDI
Length — 26.7 Millimeter FDA UDI

Intramedullary Fixation Scaffold (IFS) by Metric Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Metric Medical Devices, Inc.

Sources (1)

FDA UDI 57cafdec-fee6-4d04-a3f1-5f939ec21fd0 38 fields · synced May 30, 2026